Non-pharmaceutical systems and methods of treating the symptoms of fibromyalgia

ABSTRACT

Non-pharmaceutical systems and methods of treating the symptoms of fibromyalgia are described. The method includes administering a therapeutically effective amount of a sensory stimulus to a person, wherein the sensory stimulus includes one or more visual stimuli and one or more auditory stimuli.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 62/872,577, filed on Jul. 10, 2019, the entire disclosure ofwhich is incorporated herein by reference. This application is aContinuation-In-Part of U.S. patent application Ser. No. 16/418,561,filed on May 21, 2019 which claims the benefit of U.S. ProvisionalApplication No. 62/675,208 filed no May 23, 2018. This application isalso a Continuation-In-Part of U.S. patent application Ser. No.15/360,808, filed on Nov. 23, 2016 (now U.S. Pat. No. 10,328,236) whichclaims the benefit of U.S. Provisional Application No. 62/258,965 filedon Nov. 23, 2015.

BACKGROUND Field of the Disclosure

This disclosure generally relates to treating people suffering fromfibromyalgia, and more particularly to a non-pharmaceutical method oftreating the symptoms of fibromyalgia.

Discussion of the Background

Fibromyalgia is a medical condition characterized by chronic widespreadpain and a heightened pain response to pressure. Other symptoms includetiredness to a degree that normal activities are affected, sleepproblems and troubles with memory. Some people also report restless legssyndrome, bowel or bladder problems, numbness and tingling andsensitivity to noise, lights or temperature. Fibromyalgia is frequentlyassociated with depression, anxiety, and posttraumatic stress disorder.Other types of chronic pain are also frequently present.

The cause of fibromyalgia is unknown; however, it is believed to involvea combination of genetic and environmental factors, with each playing asubstantial role. The condition runs in families and many genes arebelieved to be involved. Environmental factors may include psychologicalstress, trauma and certain infections. The pain appears to result fromprocesses in the central nervous system and the condition is referred toas a “central sensitization syndrome.” Fibromyalgia is recognized as adisorder by the US National Institutes of Health and the AmericanCollege of Rheumatology.

The treatment of fibromyalgia can be difficult. Recommendations ofteninclude getting enough sleep, exercising regularly, and eating a healthydiet. Cognitive behavioral therapy (CBT) may also be helpful. Themedications duloxetine, milnacipran, or pregabalin may be used. Use ofopioid pain medication is controversial, with some stating theirusefulness is poorly supported by evidence and others saying that weakopioids may be reasonable if other medications are not effective.Dietary supplements lack evidence to support their use. Whilefibromyalgia can last a long time, it does not result in death or tissuedamage.

Fibromyalgia is estimated to affect 2-8% of the population. Women areaffected about twice as often as men. Rates appear similar in differentareas of the world and among different cultures. (Wikipediacontributors. “Fibromyalgia.” Wikipedia, The Free Encyclopedia.Wikipedia, The Free Encyclopedia, 26 Jun. 2019. Web. 2 Jul. 2019).

Thus, there is a need for tools and methods for treating the symptoms offibromyalgia.

SUMMARY

The present disclosure overcomes the disadvantages of the prior art byproviding a nonpharmaceutical method of treating symptoms offibromyalgia.

It is one aspect of certain embodiments to provide a method of treatingfibromyalgia. The method includes administering a therapeuticallyeffective amount of a sensory stimulus to a person, wherein the sensorystimulus includes one or more visual stimuli and one or more auditorystimuli.

It is another aspect to provide a system for treating fibromyalgia. Thesystem includes a headset configured to be worn on a head of a person;wherein the headset is configured to administer a therapeuticallyeffective amount of a sensory stimulus to the person; and wherein thesensory stimulus includes one or more visual stimuli and one or moreauditory stimuli.

It is another aspect to provide a method to treat one or more symptomsof fibromyalgia, where the symptoms may include one or more of anxiety,pain, depression, and lack of quality of sleep.

It is yet another aspect to provide a method of treating fibromyalgia.The method includes providing a headset to be worn by the person; andadministering, with the headset, the therapeutically effective amount ofa sensory stimulus to the person.

In certain embodiments sensory stimulus is provided to a person usingdevices and methods described in U.S. patent application Ser. No.15/360,808 (the '808 patent application) and in U.S. patent applicationSer. No. 15/910,252 (the '252 patent application). The '808 and '252patent applications are co-owned with the present patent application andare both herein included by way of incorporation in their entirety.

These features together with the various ancillary provisions andfeatures which will become apparent to those skilled in the art from thefollowing detailed description are attained by the method of the presentdisclosure, preferred embodiments thereof being shown with reference tothe accompanying drawings, by way of example only, wherein:

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of this disclosure and its advantages,reference is now made to the following description, taken in conjunctionwith the accompanying drawings. It is emphasized that, according tocommon practice, the various features of the drawings are not to-scale.On the contrary, the dimensions of the various features are arbitrarilyexpanded or reduced for clarity.

FIG. 1 generally illustrates a schematic diagram of a system that may beused to provide a therapeutic sensory stimulus to a person according toprinciples of the present disclosure;

FIGS. 2A, 2B, and 2C generally illustrate a bottom right perspectiveview, a rear view, and a left view, respectively, of some embodiments ofa headset of the system of FIG. 1 according to principles of the presentdisclosure;

FIG. 3 generally illustrates an exploded front view of some embodimentsof the headset of the system of FIG. 1 according to principles of thepresent disclosure;

FIG. 4 generally illustrates a flow chart of an exemplary method forproviding therapeutic auditory, visual, and/or tactile stimulusaccording to principles of the present disclosure;

FIGS. 5, 6, and 7 generally illustrate tables showing several treatmentstimulus segments of FIG. 4 according to principles of the presentdisclosure; and

FIG. 8 generally illustrates a graph showing treatment results accordingto principles of the present disclosure.

Reference symbols are used in the Figures to indicate certaincomponents, aspects or features shown therein, with reference symbolscommon to more than one Figure indicating like components, aspects orfeatures shown therein.

DETAILED DESCRIPTION

The following discussion is directed to various embodiments of thepresent disclosure. Although one or more of these embodiments may bepreferred, the embodiments disclosed should not be interpreted, orotherwise used, as limiting the scope of the disclosure, including theclaims. In addition, one skilled in the art will understand that thefollowing description has broad application, and the discussion of anyembodiment is meant only to be exemplary of that embodiment, and notintended to intimate that the scope of the disclosure, including theclaims, is limited to that embodiment.

Various embodiments described herein are directed to non-pharmaceuticalmethods of treating fibromyalgia. The methods include administering atherapeutically effective amount of a sensory stimulus to the person,resulting in a reduction of the person's perception of pain, and/or animprovement in the person's tolerance for pain.

The sensory stimulus provided to the person as described herein may beprovided over a period of time and may, in certain embodiments, comprisetwo or more simultaneous stimuli, such as a visual stimuli and anauditory stimuli. In addition, each sensory stimuli may include atemporal sequence of sensory stimuli patterns, such as a sequence ofstimuli having different frequencies, and/or a stimuli that alternatesbetween sensory organs, as by alternating between the eyes or ears orthe person. In various embodiments, the stimulus may include, but is notlimited to, one or more of: a visual stimuli to one or both eyes of theperson; an auditory stimuli to one or both ears of the person; and/or atactile stimuli to the skin of the person.

FIG. 1 is a schematic diagram of a system 100 that may be used toprovide a therapeutic sensory stimulus to a person. The system 100provides one or more stimuli outputs that a person wearing the systemmay experience as an auditory stimuli, a visual stimuli, and/or tactilestimuli. In some embodiments, the system 100 comprises a left lightsource 110L, a right light source 110R, a left vibration source 120L, aright vibration source 120R, and a controller 130 for independentlycontrolling and coordinating the action of the light and vibrationsources. Thus, for example, the system 100 may be positioned on the headof a person with the left light source 110L positioned over the left eyeto provide a left visual stimulus, the right light source 110Rpositioned over the right eye to provide a right visual stimulus, theleft vibration source 120L positioned to provide left ear auditorystimuli, and the right vibration source 120R positioned to provide rightear auditory stimuli.

In some embodiments, the left and right light sources 110L, 110R mayeach comprise light-emitting diodes, an incandescent light source havinga wavelength filter, a fluorescent light source, a backlit LCD panel, orother light source configured to provide to the person light at adesired, predetermined wavelength or wavelength range.

In some embodiments, the left and right vibration sources 120L, 120R mayeach comprise earbuds, miniature speakers, or other vibration sourcesthat can provide auditory stimuli to a person. In certain otherembodiments, the left and right vibration sources 120L, 120R maycomprise bone conduction transducers in the audible frequency range toprovide vibrations to the person's skull bone that is sensed as auditoryby the person's ear. Optionally, one or more of the left and rightvibration sources 120L, 120R may also produce vibrations that are sensedas tactile stimuli. Thus, for example, the controller 130 may providefirst signals to bone conduction transducers that vibrate or oscillateat a first frequency that can be interpreted by the person as auditorystimuli and may provide second signals at a second, lower frequency thatcan be interpreted as a tactile sensation by the person. In other words,bone conduction transducers may be adapted to provide both auditory andtactile stimulus to the person.

In some embodiments, the left and right vibration sources 120L, 120Rprovide output at specific one or more frequencies or a range offrequencies. In some embodiments, the left and right vibration sources120L, 120R are separately controlled to provide output at certain timesand to not provide output at other times. Thus, for example, a vibrationsource may be programmed to provide an output as an amplitude modulatedaudio frequency, which may be, for example and without limitation, 141Hz, 174 Hz, 232 Hz, or 256 Hz. Thus, in this example, the vibrationsource is the product of an audio frequency and a square wave.

In some embodiments, the left and right vibration sources 120L, 120Rprovide signals of slightly different frequencies to the left and rightear. This results in a binaural beats effect, wherein the personperceives a sound at a frequency that is the difference between thefrequency in the right ear and the frequency in the left ear. Thus, forexample, when a person is provided with a 200 Hz audio frequency to theleft ear and a 210 Hz audio frequency to the right ear, the person willperceive 200 Hz in the left ear, 210 Hz in the right ear, and 210 Hz-200Hz=10 Hz which appear as being provided to both ears. One skilled in theart may use this effect to provide sound at brain wave frequenciesseparately from, or in combination with, the other methods describedherein.

The system 100 may also include a sensor assembly 150 that obtains oneor more measurements from the person. Thus, for example and withoutlimitation, the sensor assembly 150 may include, or is in communicationwith, a sensor that measures some property or characteristic of theperson, including but not limited to, heart rate, heart ratevariability, body temperature, or blood pressure, and may includeelectronics that provide a signal indicative of the measurement to thecontroller 130. In other embodiments, the sensors are connected to thesensor assembly 150 by wired or wireless connectors. Thus, in variousembodiments, the sensors may include one or more: electrodes for sensingelectrical activity in the brain, as in a 2 or 4 lead EEG, a temperaturesensor, and/or a heartbeat sensor, or one or more EMG sensorspositioned, for example and without limitation, to measure eye movementto ascertain when REM sleep is reached, and/or to measure muscle tone toaid in determining states of relaxation. In certain embodiments, thecontroller 130 utilizes the signal from the sensor assembly 150 tomodify the intensity and/or timing of the light and vibration sources.

In some embodiments, the controller 130 may include: an output 131 toprovide signals to actuate the light sources 110L and 110R, thevibration sources 120L and 120R, and any other components that providesensory input to the person; an input 132 to accept signals from thesensor assembly 150; a non-transitory memory 133 for storing programmingand data for the system 100; a processor 134; and a communicationsmodule 135. The memory 133 may include instructions that are accessibleto the processor 134 for operating the components that provide sensoryinput to the person, including but not limited to the light sources 110Land 110R, the vibration sources 120L and 120R, including but not limitedto accepting input provided to the input 132 and modifying signalsprovided to the components that provide sensory input to the person,including but not limited to the light sources 110L and 110R, thevibration sources 120L and 120R. The communications module 135 providesfor the transfer of information to or from the controller 130 by wiredor wireless means.

In some embodiments, the system 100 may also provide tactile stimulus toa person by including a left tactile stimulus source and a right tactilestimulus source (not shown), each of which may be individuallycontrolled and coordinated with the controller 130 to provide tactilestimuli to a person being treated by the therapeutic system 100.

FIGS. 2A, 2B, and 2C are a bottom right perspective view, a rear view,and a left view, respectively, and FIG. 3 is an exploded front view ofthe headset 200, which is generally similar to the system 100 except asexplicitly noted.

The headset 100 may include sensor assembly 150, the controller 130, thelight sources 110L and 110R, and the vibration sources 120L and 120R.The sensor assembly 150 may also include a biometric sensor system, suchas that which is sold under the name of VALENCELL BENCHMARK™ (Raleigh,N.C.), and may include an infrared light source and detector, which canbe used to detect heart rate using pulse oximetry, an accelerator, and aprocessing unit. The sensor assembly 150 may include a sensor modulecircuit board that contains a digital optical detector system. Thisdetector may control the LEDs and converts the optical signals reflectedfrom the person's skin to digital format and may communicate over theinternal I2C bus to the PerformTek® processor. The accelerometer mayread via the internal I2C bus for activity signal.

In some embodiments, the controller 130 may include a NordicSemiconductor ASA (Oslo, Norway) model NRF51822 Multiprotocol BLUETOOTH®low energy/2.4 GHz RF System on Chip, and a VLSI Solution (Tampere,Finland) model VS1000 audio module.

In some embodiments, the light sources 110L and 110R are Lite-On, Inc.(Milpitas, Calif.) Bin G3/W2/AU model LTST-020VSKT LEDS. In someembodiments, the vibration sources 120L and 120R are Basen TechnologyCo, Ltd model PN: OEM-E170a earbuds.

In some embodiments, the sensor assembly 150 may also include aPerformTek® processor which polls sensor data over the internal I2C busand converts the raw measurements into data registers of biometricvalues (i.e. Heart Rate, Cadence, VO2) and processes those valuesfurther into higher level person assessments (i.e. Calories Burned,Distance, VO2 max, fitness level, and the period between heart ratebeats (the Heart Rate Interval, or RR Interval)). The PerformTek®processor may be configured to run algorithms to convert the raw signalsto a register array of biometric values and high-level assessments.These values may be available for reading via the UART or I2C firmwareinterface. In addition, sensor module diagnostics such as signalquality, error codes, and serial number ID may be available.

The sensor assembly 150 may further include control lines forinterfacing the controller 130 with the PerformTek® processor, and mayfurther include a Power On Self-Test (POST), UART, or I2C communicationinterface, and a wake-from-standby line (WAKE). The host processor maybe configured to control much of the functionality of the sensor modulevia a software protocol interface over the UART or I2C interface.

In some embodiments, the sensor assembly 150 may be configured todetermine a current heart rate, and/or an inter-beat R-R interval, whichmay then be provided to the controller 130. In some embodiments, thesensor assembly 150 may also provide accelerometer data to thecontroller 130.

In yet some embodiments, the sensor assembly 150 may include one or moreEEG sensors, as are known in the field, and may provide brain electricalactivity measurements to the controller 130.

In some embodiments, the sensor assembly 150 may include one or more EMGsensors positioned, for example and without limitation, to measure eyemovement to ascertain when REM sleep is reached, and/or to measuremuscle tone to aid in determining states of relaxation. EMG sensors, asare known in the field, may provide brain electrical activitymeasurements to the controller 130.

The headset 200 may also include the left and right audio jacks 201L and201R and into which the left and right earbuds 120L and 120R,respectively, may be plugged into. Alternatively, stereo headphones (notshown) may be plugged into one of the jacks 201L or 201R, where thejacks are appropriately programmed to provide stereo sound to theheadphones.

The headset 200 may be configured to administer a therapeuticallyeffective amount of a sensory stimulus to the person. The sensorystimulus may include one or more visual stimuli and one or more auditorystimuli. The visual stimuli may include at least one of an amplitudemodulated light source and a sinusoidally varying light source. Theauditory stimuli may include an amplitude modulated audio frequency. Thesensory stimulus may include two or more sensory stimuli patterns. Atleast one of the two or more sensory stimuli patterns may include afirst stimuli pattern including a first pulse frequency and a secondstimuli pattern including a second pulse frequency. One or more of thefirst pulse frequency and the second pulse frequency may be betweenapproximately 0.25 Hz and 0.75 Hz, 1.25 Hz and 1.75 Hz, 2 Hz and 4 Hz,3.75 Hz and 4.25 Hz, or 6 Hz and 9 Hz.

FIG. 4 shows a flow chart of an exemplary method 400 for providingtherapeutic auditory, visual, and/or tactile stimulus. The method 400may use, one of the system 100 or the headset 200 being configured toperform some or all of the steps of the method 400. In a step 410, asubject having pain, or who wishes to undergo a treatment for managingpain, may be identified. In a step 420, the subject may be provided thetherapeutic system or headwear, such as the headset 200 as describedabove, and in step 430, the subject places the headset on their head. Ina step 440, the headset 200 may execute the programming 450 provided inthe controller 130 to provide stimuli to the subject. The programmingmay provide two or more of auditory, visual, and/or tactile stimulus tothe subject, and thus, for example, may provide power to activate theleft light source 110L, the right light source 110R, the left vibrationsource 120L and or the right vibration source 120R. The programming mayalso include modifying the auditory, visual, and/or stimuli in responseto measurements obtained by the sensor assembly 150 and provided to thecontroller 130.

In certain embodiments, providing two or more of auditory, visual,and/or tactile stimulus concurrently may provide improved therapeuticbenefits as compared to providing only one of auditory, visual, ortactile stimulus at one time. The two or more auditory, visual, and/ortactile stimulus may thus combine to provide the improved therapeuticbenefits, for example (i.e., the two or more auditory, visual, and/ortactile stimulus may synergize in a way to provide improved results overproviding two of the stimuli individually).

Exemplary instructions for providing stimuli may be provided, forexample, by the programming 450, which may include one or moresubroutines. An exemplary subroutine is subroutine 450 e, which can beconfigured to analyze measurements obtained from sensor assembly 150 andstore the analyzed measurements in the memory 113. Another exemplarysubroutine 450 a may include instructions for the simultaneousactivation of all active auditory, visual, and/or tactile stimulussources. Optionally, the activation of all sources may include theactivation of tactile stimulation to run throughout all subsequentauditory and/or visual stimulation. Another exemplary subroutine 450 bmay include instructions for alternating the left auditory, visual,and/or tactile stimulus sources with the right auditory, visual, and/ortactile stimulus sources (i.e., the left stimuli and right stimuli taketurns being active). Another exemplary subroutine 450 c may includeinstructions for alternating the visual sources with the auditory and/ortactile sources (i.e., the visual stimuli and the auditory/tactilestimuli take turns being active). Another exemplary subroutine 450 d mayinclude instructions for alternating the left auditory and/or tactilesource and the right visual source with the right auditory and/ortactile source and the left visual source (i.e., oppositeauditory/tactile stimuli take turns being active).

In certain optional embodiments, one or more of the subroutines 450 a,450 b, 450 c, or 450 d, may be configured to access the analyzedmeasurements from the subroutine 450 e and modify the instructions theyprovide to the auditory, visual, and/or tactile stimuli depending onreal-time or near real-time measurements of the person obtained from thesensor assembly 150. Such programming is further described below.

In step 440, the programming 450, including but not limited to thesubroutines 450 a, 450 b, 450 c, and 450 d, may be configured to beapplied one or more times, individually or in combination with oneanother. The programming may be configured to further provide sequencesof output in the subroutines 450 a, 450 b, 450 c, and 450 d at differentfrequencies and/or timings. Thus, for example, the subroutines mayprovide output at specific frequencies that change as the subroutine isrepeated. The subroutines may be repeated for a predetermined timeperiod. Non-limiting examples of predetermined time periods includeapproximately 0 to 5 seconds, 5 to 10 seconds, 10 to 15 seconds, 15 to20 seconds, 20 to 25 seconds, 25 to 30 seconds, 30 to 35 seconds, 35 to40 seconds, 40 to 45 seconds, 45 to 50 seconds, 50 to 55 seconds, 55 to60 seconds, 60 to 65 seconds, 65 to 70 seconds, 70 to 75 seconds, 75 to80 seconds, 80 to 85 seconds, 85 to 90 seconds, 90 to 95 seconds, 95 to100 seconds, 100 to 105 seconds, 105 to 110 seconds, 110 to 115 seconds,115 to 120 seconds, 120 to 125 seconds, 125 to 130 seconds, 130 to 135seconds, 135 to 140 seconds, 140 to 145 seconds, 145 to 150 seconds, 150to 155 seconds, 155 to 160 seconds, 160 to 165 seconds, 165 to 170seconds, 170 to 175 seconds, 175 to 180 seconds, 0 to 10 seconds, 5 to15 seconds, 10 to 20 seconds, 15 to 25 seconds, 20 to 30 seconds, 25 to35 seconds, 30 to 40 seconds, 35 to 45 seconds, 40 to 50 seconds, 45 to55 seconds, 50 to 60 seconds, 55 to 65 seconds, 60 to 70 seconds, 65 to75 seconds, 70 to 80 seconds, 75 to 85 seconds, 80 to 90 seconds, 85 to95 seconds, 90 to 100 seconds, 95 to 105 seconds, 100 to 110 seconds,105 to 115 seconds, 110 to 120 seconds, 115 to 125 seconds, 120 to 130seconds, 125 to 135 seconds, 130 to 140 seconds, 135 to 145 seconds, 140to 150 seconds, 145 to 155 seconds, 150 to 160 seconds, 155 to 165seconds, 160 to 170 seconds, 165 to 175 seconds, 170 to 180 seconds, 0to 15 seconds, 5 to 20 seconds, 10 to 25 seconds, 15 to 30 seconds, 20to 35 seconds, 25 to 40 seconds, 30 to 45 seconds, 35 to 50 seconds, 40to 55 seconds, 45 to 60 seconds, 50 to 65 seconds, 55 to 70 seconds, 60to 75 seconds, 65 to 80 seconds, 70 to 85 seconds, 75 to 90 seconds, 80to 95 seconds, 85 to 100 seconds, 90 to 105 seconds, 95 to 110 seconds,100 to 115 seconds, 105 to 120 seconds, 110 to 125 seconds, 115 to 130seconds, 120 to 135 seconds, 125 to 140 seconds, 130 to 145 seconds, 135to 150 seconds, 140 to 155 seconds, 145 to 160 seconds, 150 to 165seconds, 155 to 170 seconds, 160 to 175 seconds, 165 to 180 seconds, 0to 20 seconds, 5 to 25 seconds, 10 to 30 seconds, 15 to 35 seconds, 20to 40 seconds, 25 to 45 seconds, 30 to 50 seconds, 35 to 55 seconds, 40to 60 seconds, 45 to 65 seconds, 50 to 70 seconds, 55 to 75 seconds, 60to 80 seconds, 65 to 85 seconds, 70 to 90 seconds, 75 to 95 seconds, 80to 100 seconds, 85 to 105 seconds, 90 to 110 seconds, 95 to 115 seconds,100 to 120 seconds, 105 to 125 seconds, 110 to 130 seconds, 115 to 135seconds, 120 to 140 seconds, 125 to 145 seconds, 130 to 150 seconds, 135to 155 seconds, 140 to 160 seconds, 145 to 165 seconds, 150 to 170seconds, 155 to 175 seconds, 160 to 180 seconds, 0 to 25 seconds, 5 to30 seconds, 10 to 35 seconds, 15 to 40 seconds, 20 to 45 seconds, 25 to50 seconds, 30 to 55 seconds, 35 to 60 seconds, 40 to 65 seconds, 45 to70 seconds, 50 to 75 seconds, 55 to 80 seconds, 60 to 85 seconds, 65 to90 seconds, 70 to 95 seconds, 75 to 100 seconds, 80 to 105 seconds, 85to 110 seconds, 90 to 115 seconds, 95 to 120 seconds, 100 to 125seconds, 105 to 130 seconds, 110 to 135 seconds, 115 to 140 seconds, 120to 145 seconds, 125 to 150 seconds, 130 to 155 seconds, 135 to 160seconds, 140 to 165 seconds, 145 to 170 seconds, 150 to 175 seconds, 155to 180 seconds, 0 to 30 seconds, 5 to 35 seconds, 10 to 40 seconds, 15to 45 seconds, 20 to 50 seconds, 25 to 55 seconds, 30 to 60 seconds, 35to 65 seconds, 40 to 70 seconds, 45 to 75 seconds, 50 to 80 seconds, 55to 85 seconds, 60 to 90 seconds, 65 to 95 seconds, 70 to 100 seconds, 75to 105 seconds, 80 to 110 seconds, 85 to 115 seconds, 90 to 120 seconds,95 to 125 seconds, 100 to 130 seconds, 105 to 135 seconds, 110 to 140seconds, 115 to 145 seconds, 120 to 150 seconds, 125 to 155 seconds, 130to 160 seconds, 135 to 165 seconds, 140 to 170 seconds, 145 to 175seconds, and 150 to 180 seconds.

In certain embodiments, the pulses that determine the amplitudemodulation above may be essentially square waves and thus, as determinedby a Fourier analysis, may be formed of sinusoidal components at thepulse frequency and at higher harmonics. As an approximation, an idealsquare wave with a pulse frequency of P contains only odd-integerharmonic frequencies at (2k−1)*P, where k=1, 2, 3 . . . , which containa fraction (2/π)/(2k−1) of the total power in the square wave. Thus, forexample, the signal power in a square wave with a pulse frequency of 4Hz may include 63% of the power at 4 Hz, 21% of the power at 12 Hz, 13%of the power at 20, etc. If the square wave does not have equal on andoff periods, then the pulse frequency will also contain even-integerharmonic frequencies.

Thus, for example, subroutine 450 a may be configured to provideamplitude modulated auditory output to the vibration source 120R or 120Lat a carrier audio frequency of 256 Hz that is turned on and off, thatis it is pulsed, at a pulse frequency of 1 Hz for 2 minutes, or mayprovide amplitude modulated light output to the light source 110R or110L that produces at a carrier light wavelength 580 nm that is turnedon and off, that is it is pulsed at a at a pulse frequency of 1 Hz for 2minutes. This square pulse auditory or light signal may thus generatessignals at a frequency of 1 Hz in addition to higher harmonics.Non-limiting ranges for pulse frequencies may include from approximately0.5 Hz to 1 Hz, 1 Hz to 2 Hz, 2 Hz to 3 Hz, 3 Hz to 4 Hz, 4 Hz to 5 Hz,5 Hz to 6 Hz, 6 Hz to 7 Hz, 7 Hz to 8 Hz, 8 Hz to 9 Hz, 9 Hz to 10 Hz,10 Hz to 11 Hz, 11 Hz to 12 Hz, 12 Hz to 13 Hz, 13 Hz to 14 Hz, 14 Hz to15 Hz, 15 Hz to 16 Hz, 16 Hz to 17 Hz, 17 Hz to 18 Hz, 18 Hz to 19 Hz,19 Hz to 20 Hz, 1 Hz to 3 Hz, 2 Hz to 4 Hz, 3 Hz to 5 Hz, 4 Hz to 6 Hz,5 Hz to 7 Hz, 6 Hz to 8 Hz, 7 Hz to 9 Hz, 8 Hz to 10 Hz, 9 Hz to 11 Hz,10 Hz to 12 Hz, 11 Hz to 13 Hz, 12 Hz to 14 Hz, 13 Hz to 15 Hz, 14 Hz to16 Hz, 15 Hz to 17 Hz, 16 Hz to 18 Hz, 17 Hz to 19 Hz, 18 Hz to 20 Hz, 1Hz to 4 Hz, 2 Hz to 5 Hz, 3 Hz to 6 Hz, 4 Hz to 7 Hz, 5 Hz to 8 Hz, 6 Hzto 9 Hz, 7 Hz to 10 Hz, 8 Hz to 11 Hz, 9 Hz to 12 Hz, 10 Hz to 13 Hz, 11Hz to 14 Hz, 12 Hz to 15 Hz, 13 Hz to 16 Hz, 14 Hz to 17 Hz, 15 Hz to 18Hz, 16 Hz to 19 Hz, 17 Hz to 20 Hz. Non-limiting examples of ranges forcarrier light wavelength may include from approximately 380 nm to 400nm, 390 nm to 410 nm, 400 nm to 420 nm, 410 nm to 430 nm, 420 nm to 440nm, 430 nm to 450 nm, 440 nm to 460 nm, 450 nm to 470 nm, 460 nm to 480nm, 470 nm to 490 nm, 480 nm to 500 nm, 490 nm to 510 nm, 500 nm to 520nm, 510 nm to 530 nm, 520 nm to 540 nm, 530 nm to 550 nm, 540 nm to 560nm, 550 nm to 570 nm, 560 nm to 580 nm, 570 nm to 590 nm, 580 nm to 600nm, 590 nm to 610 nm, 600 nm to 620 nm, 610 nm to 630 nm, 620 nm to 640nm, 630 nm to 650 nm, 640 nm to 660 nm, 650 nm to 670 nm, 660 nm to 680nm, 670 nm to 690 nm, and 680 nm to 700 nm. One or more of thenon-limiting examples of pulse frequencies may be used in conjunctionwith one or more of the non-limiting examples of carrier wavelength.

In certain embodiments, the subroutines described herein generate pulseshaving sinusoidal components that correspond with certain known brainwave frequencies (i.e., frequencies of neural oscillations, orrepetitive patterns of activity in the brain), which are generallyaccepted as being delta waves (0.1 to 4.0 Hz), theta brain waves (4 to 7Hz), alpha brain waves (8 to 15 Hz), beta brain waves (16 to 31 Hz), andgamma brain waves (32 to 100 Hz). A person skilled in the art willappreciate that the precise boundaries of these ranges may vary fromthose provided in the present disclosure, and other ranges for deltabrain waves, theta brain waves, alpha brain waves, beta brain waves, andgamma brain waves can be considered without departing from the presentdisclosure. Thus, certain embodiments may include pulse frequencies fromapproximately 3.75 Hz to 4.25 Hz (theta brain waves), from 1.25 Hz to1.75 Hz (delta brain waves), and/or from 0.25 Hz and 0.75 Hz (deltabrain waves). Other non-limiting ranges for pulse frequencies mayinclude from approximately 0.5 Hz to 1 Hz (delta brain waves), 1 Hz to 2Hz (delta brain waves), 2 Hz to 3 Hz (delta brain waves), 3 Hz to 4 Hz(delta brain waves), 4 Hz to 5 Hz (theta brain waves), 5 Hz to 6 Hz(theta brain waves), 6 Hz to 7 Hz (theta brain waves), 7 Hz to 8 Hz(beta brain waves), 8 Hz to 9 Hz (beta brain waves), 9 Hz to 10 Hz (betabrain waves), 10 Hz to 11 Hz (beta brain waves), 11 Hz to 12 Hz (betabrain waves), 12 Hz to 13 Hz (beta brain waves), 13 Hz to 14 Hz (betabrain waves), 14 Hz to 15 Hz (beta brain waves), 15 Hz to 16 Hz (betabrain waves), 16 Hz to 17 Hz (beta brain waves), 17 Hz to 18 Hz (betabrain waves), 18 Hz to 19 Hz (beta brain waves), 19 Hz to 20 Hz (betabrain waves), 1 Hz to 3 Hz (delta brain waves), 2 Hz to 4 Hz (deltabrain waves), 3 Hz to 5 Hz (delta/theta brain waves), 4 Hz to 6 Hz(theta brain waves), 5 Hz to 7 Hz (theta brain waves), 6 Hz to 8 Hz(theta/beta brain waves), 7 Hz to 9 Hz (beta brain waves), 8 Hz to 10 Hz(beta brain waves), 9 Hz to 11 Hz (beta brain waves), 10 Hz to 12 Hz(beta brain waves), 11 Hz to 13 Hz (beta brain waves), 12 Hz to 14 Hz(beta brain waves), 13 Hz to 15 Hz (beta brain waves), 14 Hz to 16 Hz(beta brain waves), 15 Hz to 17 Hz (beta brain waves), 16 Hz to 18 Hz(beta brain waves), 17 Hz to 19 Hz (beta brain waves), 18 Hz to 20 Hz(beta brain waves), 1 Hz to 4 Hz (delta brain waves), 2 Hz to 5 Hz(delta/theta brain waves), 3 Hz to 6 Hz (delta brain waves), 4 Hz to 7Hz (theta brain waves), 5 Hz to 8 Hz (theta/beta brain waves), 6 Hz to 9Hz (theta/beta brain waves), 7 Hz to 10 Hz (beta brain waves), 8 Hz to11 Hz (beta brain waves), 9 Hz to 12 Hz (beta brain waves), 10 Hz to 13Hz (beta brain waves), 11 Hz to 14 Hz (beta brain waves), 12 Hz to 15 Hz(beta brain waves), 13 Hz to 16 Hz (beta brain waves), 14 Hz to 17 Hz(beta brain waves), 15 Hz to 18 Hz (beta brain waves), 16 Hz to 19 Hz(beta brain waves), 17 Hz to 20 Hz (beta brain waves). Further,individual pulse frequencies may vary within these ranges (e.g.,shifting from 18.5 Hz to 16.5 Hz, while remaining in the 16 Hz to 19 Hzrange).

Further, multiple pulse frequencies may be provided sequentially or atthe same time. For example, a first pulse frequency may include a rangeof frequencies of approximately 12 Hz to 14 Hz, a second pulse frequencyfollowing the first pulse frequency may include a range of frequenciesof approximately 8 Hz to 10 Hz range, a third pulse frequency followingthe second pulse frequency may include a range of frequencies ofapproximately 5 Hz to 6 Hz range, and a fourth pulse frequency followingthe third pulse frequency may include a range of frequencies ofapproximately 3.75 Hz range to a 4.25 Hz range. In some embodiments,different pulse frequencies or segments associated with different pulsefrequencies may be distinguishable from one another by discontinuitiesin frequency (e.g., a first pulse frequency in a range of frequencies ofapproximately 6.6 Hz to 8 Hz being immediately followed by another pulsefrequency in range of frequencies of approximately 4 Hz to 6.3 Hz),while in other embodiments, different pulse frequencies or segmentsassociated with different pulse frequencies may be distinguishable fromone another by changes in a rate of change of the pulse frequency (e.g.,a decreasing pulse frequency in range of frequencies of approximately 4Hz to 6 Hz being immediately followed by an increasing pulse frequencyin range of frequencies of approximately 4 Hz to 5.2 Hz or a firstincreasing pulse frequency in range of frequencies of approximately 3.9Hz to 4.4 Hz being immediately followed by a second increasing pulsefrequency in range of frequencies of approximately 4.4 Hz to 6 Hz thatis increasing in frequency more rapidly than the first increasing pulsefrequency was increasing). Further, differences between stimuli patternscan include differences other than pulse frequency. As non-limitingexamples, stimuli patterns may be different in duration, intensity(i.e., peak amplitude), or wavelength (i.e., color or pitch).

In addition, by altering the output between left and right channels, thebrain may be stimulated in a way that it is forced to communicatebetween the left and right sides of the brain. This forcedcommunication, for example, can allow PTSD memories to be wired to bothsides of the brain, thereby stopping undesirable flashbacks. It can alsocreate an enhanced relaxation effect, allowing for deeper relaxation andpain management.

In some embodiments, the system 100 may be configured to provide astimulus that may include visual and auditory stimuli over threetemporally sequential segments—a first segment where stimuli occurs at afirst frequency, followed by a second segment where stimuli occurs at asecond frequency, which was followed by a third segment where stimulioccurs at a third frequency. Each time segment included sub-segments ofvisual and auditory stimuli, where each sub-segment was determined byone of the subroutines described above, for example. The visual stimuliwere provided by pulsing light at a wavelength of 580 nm at certainpulse frequencies and by pulsing auditory signals at a frequency of 256Hz at certain pulse frequencies, though a person having skill in the artwill understand that other wavelengths and other pulse frequencies mayalso be considered.

In some embodiments, a treatment stimulus lasted for 16 minutes, and maybe understood by reference to Table 500 in FIG. 5 , Table 600 in FIG. 6, and Table 700 in FIG. 7 , where Table 500 contains specifications forthe first segment (“Segment A”), Table 600 contains specifications forthe next, second time segment (“Segment B”), and Table 700 containsspecifications for the last time segment (“Segment C”). Each of theSegments stimuli patterns at a different pulse frequency. Specifically,Segment A cycles the stimuli through a block of four Segment A stimulipatterns for a total of 2 minutes, Segment B cycles the stimuli througha block of four Segment B stimuli patterns for a total of 2 minutes, andSegment C cycles the stimuli through a block of six Segment C stimulipatterns for a total of 12 minutes.

More specifically, in the four Segment A stimuli patterns, as shown inTable 500 as Blocks A1, A2, A3, and A4 respectively, the auditory andlight outputs cycle 115 or 116 times between being on for 0.1277 secondsand then being off for 0.1277 seconds (that is, at a pulse frequency of3.9 Hz), followed by no output for 0.5 seconds. In the Segment B stimulipatterns, as shown in Table 600 as Blocks B1, B2, B3 and B4, theauditory and light outputs cycle 44 or 45 times between being on for0.3333 seconds and then being off for 0.3333 seconds (that is, at apulse frequency of 1.5 Hz) followed by no output for 0.5 seconds. In theSegment C stimuli patterns, as shown in Table 700 and labeled Blocks C1,C2, C3 and C4, the auditory and light outputs cycle 14 or 15 timesbetween being on for 1 second and then being off for 1 second (that is,a pulse frequency of 0.5 Hz), followed by no output for 1 second. BlocksA1, B1, and C1 pulse the right and left sides of both the light andauditory together, with all outputs are synchronized to be on or off atthe same time, as provided by the subroutine 450 a. Blocks A2, B2, andC2 synchronize the left side light and auditory output, and the rightside light and auditory output to be opposite to one another, asprovided by the subroutine 450 b. Blocks A3, B3, and C3 synchronize bothlights together to be opposite to both auditory outputs, as provided bysubroutine the 450 c. Blocks A4, B4, and C4 synchronize the rightauditory and light to be opposite to the left auditory and lightoutputs, as provided by subroutine 450 d.

Other examples segmented stimuli patterns include treatment lasting fora total of approximately 16 minutes. This example starts with a firstpulse frequency of approximately 20 Hz, followed by a second pulsefrequency that decreases over time to approximately 1 Hz, followed by athird pulse frequency that increases over time to approximately 17 Hz,followed by further pulse frequencies that continue to increase anddecrease while narrowing in on an extended period at a steady pulsefrequency of approximately 5 Hz for approximately 4 to 5 minutes, andreturning to a final pulse frequency of 20 Hz.

In step 440, the subroutine 450 e may be configured to receivemeasurements from the sensor assembly 150 and store analyzedmeasurements. In some embodiments, the sensor assembly 150 may beconfigured to provide instantaneous, or nearly instantaneous,measurements from the person. Thus, for example and without limitation,the sensor assembly 150 may provide a sequence of measurements ofbeat-to-beat intervals of the heart of the person, that is, the timeinterval between the last two heart beats, which is also referred to,without limitation, as the RR intervals. The controller 130 may beconfigured to compute and store values of the heart rate variability(HRV), which is a mathematical representation of the physiologicalphenomenon of variation in the time interval between heartbeats.

In certain embodiments, a time-domain calculation of RR intervals, asobtained by the sensor assembly 150, may be used to compute the HRV.Thus, for example, the sequence of RR intervals (“RRi”) may be acceptedfrom the sensor assembly 150 and stored in the memory 133. After theaccumulation RRi for a period of time, T, the HRV may be calculated asapproximated by the root mean square of successive differences betweenadjacent RRs, or RMSSD. Thus, at a time T from the beginning of theaccumulation of data, if N consecutive RR intervals are stored in thememory 133, the following calculation may be performed in the processor134 according to a program stored in the memory:

${RMSSD} = \sqrt{\frac{1}{N - 1}\left( {\sum_{i - 1}^{N - 1}\left( {{RR}_{i + 1} - {RR}_{i}} \right)^{2}} \right)}$

The initial value of RMSSD (that is, RMSSD0) may be stored in the memory133 as a baseline. Thereafter, at the end of each period T, thecalculation of RMSSD may be repeated covering that time period. As aresult, a sequence of RMSSDj values may be computed. Next the differencebetween the current RMSSD value and the baseline RMSSD0 may be computedas ΔRMSSDj=RMSSDj−RMSSD0. ΔRMSSD is a measure of the change between thecurrent HRV and the baseline, initial HRV.

In general, it is realized by those skilled in the art, that anincreased in HRV may be associated with a relaxed state, or a sleepstate, and that a decrease in HRV may be associated with a less relaxed,or stressed, state. For uses of the therapeutic system 100 intended tocalm a person or to induce sleep, a positive ΔRMSSD may indicate thatthe person is becoming relaxed and that the system is working asintended. A negative ΔRMSSD may indicate that the person is not becomingmore relaxed. In some embodiments, an indication that the person isrelaxed (ΔRMSSD>0) may be used to modify the treatment by reducing thetreatment time and/or intensity of the stimuli, and an indication thatthe person is less relaxed (ΔRMSSD<0) may be used to modify thetreatment to increase the treatment time and/or the intensity of thestimuli.

In certain embodiments, Kubios HRV software (manufactured by Kuopio,Finland) may be used to analyze the RR intervals to provide additionalHRV related data. Thus, for example, one useful measure for analyzingHRV may be the fraction of the power of the HRV signal that occurs incertain frequency ranges. Thus, for example, one measure which isreferred to herein as HRV-HFnu may be obtained by taking the Fouriertransform of the HRV signal and computing the ratio of the power of theHRV signal from 0.15 to 0.40 Hz (“high frequencies”) to the total powerof the HRV signal.

The calculations described above are provided by way of explanation andare not meant to limit the scope of the calculations or how theoperation of the therapeutic system 100 is or is not modified using HRVmeasurements.

Although the above steps show the method 400 of treating a patient inaccordance with certain embodiments, a person of ordinary skill in theart will recognize many variations based on the teaching describedherein. The steps may be completed in a different order. Steps may beadded or deleted. Some of the steps may comprise sub-steps. Many of thesteps may be repeated as often as beneficial to the treatment.

One or more of the steps of the method 400 may be performed with thecircuitry as described herein, for example, circuitry of the controller130 or the external control unit 130 a such as one or more of aprocessor or logic circuitry such as a central processing unit (CPU) ora programmable array logic for field programmable gate array. Thecircuitry may be programmed to provide one or more of the steps of themethod 400, and the program may comprise program instructions stored ona computer readable memory or programmed steps of the logic circuitrysuch as the programmable array logic or the field programmable gatearray, for example.

A Study of the Treatment of Fibromyalgia

A study was conducted on the effectiveness of the method for treatingfibromyalgia using the headset 200. A single arm trial was conducted byPI Dr. Mark Kuchar, DC, CSCS at Southpointe Clinic, Colorado.

Protocol

A group of 8 participants were selected for testing the effectiveness ofthe headset 200 in treating fibromyalgia. Each of the participants wereconsidered to be treatment resistant—that is, they experienced noimprovement from other modalities or placebo and had previously failedon all drug regimens and a 90 day best standard of care protocol.

The study was divided into 3 phases: Screening and Baseline, Treatment,and Follow-up. Each patient participated in the study for up to 32 days,including Screening and Baseline (up to 7 days), Treatment (15 days),and Follow-up (up to 10 days).

Screening and Baseline procedures were performed within 7 days ofadmission to the Treatment Phase. Participants were instructed to ratetheir pain intensity and sleep quality, and record their concomitantmedication use on a daily basis using a logbook.

On Day 1 of the Treatment Phase, eligible participants were instructedon the use of receiving a treatment from the headset 200 and used thedevice for the first time under clinic supervision; all other uses ofthe device were conducted at home. During the Treatment Phase,participants underwent at least 2 daily treatments with the headset 200,including a treatment immediately prior to bedtime. Additionaltreatments were allowed, as needed (PRN), at the participant'sdiscretion.

Pain intensity was assessed, as described subsequently, prior to eachtreatment and, with the exception of the bedtime treatment, within 5minutes of completion of each treatment. Participants recorded painintensity and sleep quality, as discussed subsequently, upon waking inthe morning, and recorded the use of medications/non-pharmacologicaltherapies on a daily basis prior to bedtime.

During the Treatment Phase, participants attended the study site on Day1 of the Treatment Phase, and on Day 15 of the Treatment Phase. At eachstudy visit, assessments of sleep quality, depression and anxiety, useof concomitant medications/non-pharmacological therapies and compliancewith the headset 200 were completed. On Day 8 of the Treatment Phase(+/−1 day) participants received a phone call to confirm compliance withuse of the headset 200, answer questions and check for adverse events(AEs). Assessments of AEs and treatment acceptability were also beconducted during the Treatment Phase. A Follow-up call was scheduledwithin 7 days (±3 days) of completing the Treatment Phase.

The following concomitant medications and therapies were permittedduring the study:

-   -   Nonsteroidal anti-inflammatory drugs (NSAIDs) were permitted        occasionally for headache, fever, or other indications aside        from chronic pain, for no more than 3 consecutive days and no        more than the maximum daily recommended dose. NSAIDs were not be        permitted during the Baseline period and the last 3 days of the        Treatment Phase.    -   Opioid and non-opioid analgesics were permitted, but        participants were required to be on a stable dose (±20% dose and        timing of administration) for at least 14 days prior to        enrollment.    -   Anti-constipation medications.    -   Aspirin at doses ≤325 mg/day for cardiovascular prophylaxis.

The following medications and therapies were permitted, and remainedstable (±20% dose and timing of administration) throughout the durationof the participant's participation in the study: muscle relaxants,hypnotics (eszopiclone, zolpidem, zaleplon), antidepressants,anticonvulsants, benzodiazepines, physical therapy, biofeedback therapy,acupuncture therapy, and herbal remedies (except for St. John's Wort).

On a case-by-case basis, the investigator was permitted to allow the useof some concomitant medications, for example, to treat an AE, as long asthe investigator determined that the medication would not affect thepatient's safety or study integrity. The following regimens werepermitted:

-   -   Supplemental medications including either 1000 mg acetaminophen        up to 2 times per day, 550 mg naproxen up to 2 times per day, or        800 mg/day ibuprofen up to 4 times per day, up to the maximum        daily dose (i.e., either up to 2000 mg/day acetaminophen, up to        1100 mg/day naproxen, or up to 3200 mg/day ibuprofen).    -   Use of any analgesic medications or non-pharmacological        therapies where be recorded (date, time, medication name, dose,        regimen, etc.).

All 8 participants elected to continue using the device and stated anintention to use it as part of their treatment regimen, and oneparticipant was able to discontinue use of alprazolam (Xanax) early instudy.

Measures of Symptoms of Fibromyalgia

In the study discussed subsequently, test subjects were provided with anumber of sensory stimuli and their response to the treatment wasdetermined using subjective measures using the following questionnaires:

-   -   Pain Intensity Visual Analog Scale (VAS) (or “VAS-Pain”), which        prompts the patient to rate “How I feel” on a VAS, ranging from        between “No Pain,” which is assigned a value of zero, to “Worst        Pain Imaginable,” which is assigned a value of 100. See, for        example, img.medscape.com/article/742/580/VAS.pdf.    -   Pittsburgh Sleep Quality Index (PSQI), which presents questions        used to measure the quality and patterns of sleep in adults). It        differentiates “poor” from “good” sleep quality by measuring        seven areas (components): subjective sleep quality, sleep        latency, sleep duration, habitual sleep efficiency, sleep        disturbances, use of sleeping medications, and daytime        dysfunction over the last month. See, for example        https://www.opapc.com/uploads/documents/PSQI.pdf. The score on        the PSQI ranges from 0-21, where higher scores indicate worse        sleep quality.    -   Patient Health Questionnaire (PHQ-9), which presents questions        related to depression. The PHQ-9 is a validated tool for        screening, diagnosing, monitoring and measuring depression        severity, and scores each of the 9 Diagnostic and Statistical        Manual of Mental Disorder, Fourth Edition (DSM-IV) related        criteria.    -   Generalized Anxiety Disorder 7-item (GAD-7) Scale, presents        question to the patient for screening and measuring severity of        generalized anxiety. See, for example        https://www.mdcalc.com/gad-7-general-anxiety-disorder-7. The        score on the GAD-7 Scale range from 0-21, where a score of 5-9        is interpreted as a level of mild anxiety, a score of 10-14 is        interpreted as a moderate level of anxiety, having possible        clinical significance, and a score of 15 or greater is        interpreted as a severe level of anxiety, likely warranting        active treatment.    -   Patient Global Impression of Change (PGIC) is a commonly used        tool that is recommended to assess a patient's overall        satisfaction with their treatment. The patent is prompted to        indicate whether there has been any change in their activity        limitations, symptoms, emotions and overall quality of life, as        related to their pain condition, since the start of the study        (1=No change to 7=A great deal better). In addition, patients        rate the degree of change since beginning treatment on a 0 (Much        Better) to 10 (Much Worse) scale. Patients completed the PGIC on        Day 15 or early discontinuation.    -   Likelihood to Use Device Again question, in which patients        answered the question “If the device was available, how likely        would you be to continue use of the device,” of the headset 200.        Response options range from extremely likely, very likely,        somewhat likely, not very likely, to not at all likely.        Study Results

The following is a comparison of the average baseline measures if pain,anxiety, depression, quality of sleep for all 8 participants with thesame measures after the Treatment Phase.

The average VAS-Pain score for all study participants was 62.7 atbaseline and 46.5 at the end of treatment, with a P value of 0.0754.This is a 26% decrease in the VAS-Pain score, corresponding to adecrease in perceived pain from “intense” to “distressing.” Further, itwas found that the treatment worked best for participants with thegreatest amount of pain, as those with the severest amounts of painpatients had a reduction of VAS-Pain scores of 49%.

The average GAD 7 scale scores, which is a measure of anxiety, was 11 atbaseline and 6.25 at the end of treatment, with a P value of 0.0096,which indicates a high level of level of statistical certainty. This isa 43% decrease in the anxiety scores and corresponds to a decrease inperceived anxiety from “moderate” to “mild.”

The average PHQ9 scale scores, which is a measure of depression was 15.5before the study and 8.75 at the end of treatment, with a P value of0.0024, which indicates a high level of level of statistical certainty.This is a 44% decrease in the anxiety scores and corresponds to adecrease in perceived depression from “moderately severe” to “mild.”

The PSQI scale scores for each participant is shown in graph 800 of FIG.8 . The results indicate that the quality of sleep improved by 28% overthe course of treatment, with a P value of 0.0033, which indicates ahigh level of level of statistical certainty.

The results of the Likelihood to Use Device Again survey at the end ofthe Treatment Phase indicated that 6 of 8 of the participants would be“Very Likely” to use the device, if it was offered to them.

The results of the Quality of Life Likelihood to Adopt Device survey atthe end of the Treatment Phase indicated that 6 of 8 of the participantswould be “Very Likely” to use the device, if it was offered to them.

The results of the Patient Global Impression of Change (PGIC) surveyshows that most patients indicated that the Treatment Phase provided a“Definite improvement that has made a real and worthwhile difference” orhigher on the PGIC survey and provided an improvement in the quality oflife.

Some embodiments of each of the methods described herein is in the formof a computer program that executes on a processing system, e.g., one ormore processors that are part of the system 100. Thus, as will beappreciated by those skilled in the art, embodiments of the presentdisclosure may be embodied as a method, an apparatus such as a specialpurpose apparatus, an apparatus such as a data processing system, or acarrier medium, e.g., a computer program product. The carrier mediumcarries one or more computer readable code segments for controlling aprocessing system to implement a method. Accordingly, aspects of thepresent disclosure may take the form of a method, an entirely hardwareembodiment, an entirely software embodiment or an embodiment combiningsoftware and hardware aspects. Furthermore, the present disclosure maytake the form of carrier medium (e.g., a computer program product on acomputer-readable storage medium) carrying computer-readable programcode segments embodied in the medium. Any suitable computer readablemedium may be used, including a magnetic storage device (e.g., adiskette or a hard disk), a solid state memory, or an optical storagedevice (e.g., a CD-ROM).

Reference throughout this specification to “some embodiments” or “anembodiment” means that a particular feature, structure or characteristicdescribed in connection with the embodiment is included in at least someembodiments of the present disclosure. Thus, appearances of the phrases“in some embodiments” or “in an embodiment” in various places throughoutthis specification are not necessarily all referring to the sameembodiment, nor necessarily all referring to different embodiments.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner, as would be apparent to one ofordinary skill in the art from this disclosure, in one or moreembodiments.

Similarly, it should be appreciated that in the above description ofexemplary embodiments of the disclosure, various features of thedisclosure are sometimes grouped together in a single embodiment,figure, or description thereof for the purpose of streamlining thedisclosure and aiding in the understanding of one or more of the variousinventive aspects. This method of disclosure, however, is not to beinterpreted as reflecting an intention that the claimed inventionrequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment.

Thus, the claims following the Detailed Description are hereby expresslyincorporated into this Detailed Description, with each claim standing onits own as a separate embodiment of this disclosure.

Consistent with the above disclosure, the examples of systems andmethods enumerated in the following clauses are specificallycontemplated and are intended as a non-limiting set of examples.

Clause 1. A method of treating fibromyalgia, comprising:

administering a therapeutically effective amount of a sensory stimulusto a person, wherein the sensory stimulus includes one or more visualstimuli and one or more auditory stimuli.

Clause 2. The method of the preceding clause, further comprising:

treating one or more symptoms of fibromyalgia, wherein the one or moresymptoms are selected from a group including anxiety, pain, depression,and one or more sleep disorders.

Clause 3. The method of any preceding clause, wherein at least one ofthe one or more visual stimuli includes an amplitude modulated lightsource.

Clause 4. The method of any preceding clause, wherein at least one ofthe one or more visual stimuli includes a sinusoidally varying lightsource.

Clause 5. The method of any preceding clause, wherein at least one ofthe one or more auditory stimuli includes an amplitude modulated audiofrequency.

Clause 6. The method of any preceding clause, wherein the sensorystimulus includes two or more sensory stimuli patterns.

Clause 7. The method of any preceding clause, wherein at least one ofthe two or more sensory stimuli patterns includes a first stimulipattern comprising a first pulse frequency and a second stimuli patterncomprising a second pulse frequency.

Clause 8. The method of any preceding clause, wherein at least one ofthe first pulse frequency and the second pulse frequency is betweenapproximately 0.25 Hz and 0.75 Hz, 1.25 Hz and 1.75 Hz, 2 Hz and 4 Hz,3.75 Hz and 4.25 Hz, or 6 Hz and 9 Hz.

Clause 9. The method of any preceding clause, wherein the first stimulipattern includes a pulse frequency between approximately 0.25 Hz and0.75 Hz, 1.25 Hz and 1.75 Hz, 2 Hz and 4 Hz, 3.75 Hz and 4.25 Hz, or 6Hz and 9 Hz; and

wherein the second stimuli pattern includes a pulse frequency that isbetween approximately 0.25 Hz and 0.75 Hz, 1.25 Hz and 1.75 Hz, 2 Hz and4 Hz, 3.75 Hz and 4.25 Hz, or 6 Hz and 9 Hz.

Clause 10. The method of any preceding clause, wherein the two or moresensory stimuli patterns include a third stimuli pattern, wherein thethird stimuli pattern is different from the first stimuli pattern andthe second stimuli pattern.

Clause 11. The method of any preceding clause, wherein the sensorystimulus alternates between

a first sensory stimuli including simultaneously providing a left visualstimuli pattern to a left eye of the person and a right auditory stimulipattern to a right side of a head of the person, and

a second sensory stimuli including simultaneously providing a rightvisual stimuli pattern to a right eye of the person and a left auditorystimuli pattern to a left side of the head of the person,

wherein one or more of the left auditory stimuli patterns and the rightauditory stimuli patterns comprises a sequence of stimuli patternsincluding a first stimuli pattern, a second stimuli pattern, and a thirdstimuli pattern.

Clause 12. The method of any preceding clause, further comprising:

periodically providing a sensory stimuli including simultaneouslyproviding a left visual stimuli pattern to the left eye of the person, aright visual stimuli pattern to the right eye of the person, a leftauditory stimuli pattern to the left side of the head, and a rightauditory stimuli pattern to the right side of the head of the person.

Clause 13. The method of any preceding clause, further comprising:

alternating sensory stimuli between

a third sensory stimuli including simultaneously providing a left visualstimuli pattern to the left eye of the person and a left auditorystimuli pattern to the left side of the head, and

a fourth sensory stimuli including simultaneously providing a rightvisual stimuli pattern to the right eye of the person and a rightauditory stimuli pattern to the right side of the head of the person.

Clause 14. The method of any preceding clause, further comprising:

alternating sensory stimuli between

a fifth sensory stimuli including simultaneously providing a leftauditory stimuli pattern to the left side of the head and a rightauditory stimuli pattern to the right side of the head, and

a sixth sensory stimuli including simultaneously providing a left visualstimuli pattern to the left eye of the person and a right visual stimulipattern to the right eye of the person.

Clause 15. The method of any preceding clause, further comprising:

providing a headset to be worn on a head of the person; and

wherein the left auditory stimuli pattern comprises generating the leftauditory stimuli pattern with a left bone conduction transducer of theheadset; and wherein the right auditory stimuli pattern comprisesgenerating the right auditory stimuli pattern with a right boneconduction transducer of the headset.

Clause 16. The method of any preceding clause, wherein one or more ofthe left auditory stimulus pattern or the right auditory stimuli patternincludes an auditory frequency of approximately 240 Hz to 480 Hz.

Clause 17. The method of any preceding clause, wherein one or more ofthe left visual stimuli pattern or right visual stimuli patterncomprises repeatedly pulsing a light at one or more of a first pulsefrequency, a second pulse frequency less than the first pulse frequency,or a third pulse frequency less than the first pulse frequency and thesecond pulse frequency.

Clause 18. The method of any preceding clause, wherein at least one ofthe first stimuli pattern, the second stimuli pattern, the third stimulipattern, or repeatedly pulsing a light occurs for a predetermined timeinterval.

Clause 19. The method of any preceding clause, wherein the predeterminedtime interval is between approximately 25 and 45 seconds.

Clause 20. The method of any preceding clause, wherein the sequence ofstimuli patterns each include a pulse frequency including a pulseperiod, wherein a portion of the pulse period includes a stimulus of anauditory frequency of between approximately 240 Hz and 480 Hz.

Clause 21. The method of any preceding clause, wherein the portion ofthe pulse period is one half of the pulse period.

Clause 22. The method of any preceding clause, wherein one or more ofthe first stimuli pattern, the second stimuli pattern, or the thirdstimuli pattern includes a pulse frequency corresponding to a deltabrain wave frequency, a theta brain wave frequency, or an alpha brainwave frequency.

Clause 23. The method of any preceding clause, further comprising:

obtaining a measurement of the person using a sensor;

determining a state of the person from the obtained measurement; and

modifying the sensory stimulus according to the state of the person.

Clause 24. The method of any preceding clause, wherein the sensorcomprises at least one of a heart rate sensor, a heart rate variability(HRV) sensor, a temperature sensor, a motion sensor, a galvanic skinresponse sensor, an accelerometer, an EEG, and an EMG.

Clause 25. The method of any preceding clause, wherein the state of theperson comprises a state of sleep or a level or a change in a level ofrelaxation or a level of arousal.

Clause 26. A system for treating fibromyalgia, comprising:

a headset configured to be worn on a head of a person; wherein theheadset is configured to administer a therapeutically effective amountof a sensory stimulus to the person; and wherein the sensory stimulusincludes one or more visual stimuli and one or more auditory stimuli.

Clause 27. The system of any preceding clause, wherein at least one ofthe one or more visual stimuli includes at least one of an amplitudemodulated light source and a sinusoidally varying light source; and

wherein at least one of the one or more auditory stimuli includes anamplitude modulated audio frequency.

Clause 28. The system of any preceding clause, wherein the sensorystimulus includes two or more sensory stimuli patterns, wherein at leastone of the two or more sensory stimuli patterns includes a first stimulipattern including a first pulse frequency and a second stimuli patternincluding a second pulse frequency.

Clause 29. The system of any preceding clause, wherein at least one ofthe first pulse frequency and the second pulse frequency is betweenapproximately 0.25 Hz and 0.75 Hz, 1.25 Hz and 1.75 Hz, 2 Hz and 4 Hz,3.75 Hz and 4.25 Hz, or 6 Hz and 9 Hz.

Clause 30. The system of any preceding clause, wherein the first pulsefrequency is between approximately 0.25 Hz and 0.75 Hz, 1.25 Hz and 1.75Hz, 3.75 Hz and 4.25 Hz, 2 Hz and 4 Hz, or 6 Hz and 9 Hz; and

wherein the second pulse frequency is between approximately 0.25 Hz and0.75 Hz, 1.25 Hz and 1.75 Hz, 2 Hz and 4 Hz, 3.75 Hz and 4.25 Hz, or 6Hz and 9 Hz.

No part of the description in this application should be read asimplying that any particular element, step, or function is an essentialelement that must be included in the claim scope. The scope of patentedsubject matter is defined only by the claims. Moreover, none of theclaims is intended to invoke 25 U.S.C. § 104(f) unless the exact words“means for” are followed by a participle.

The foregoing description, for purposes of explanation, use specificnomenclature to provide a thorough understanding of the describedembodiments. However, it should be apparent to one skilled in the artthat the specific details are not required to practice the describedembodiments. Thus, the foregoing descriptions of specific embodimentsare presented for purposes of illustration and description. They are notintended to be exhaustive or to limit the described embodiments to theprecise forms disclosed. It should be apparent to one of ordinary skillin the art that many modifications and variations are possible in viewof the above teachings.

The above discussion is meant to be illustrative of the principles andvarious embodiments of the present disclosure. Once the above disclosureis fully appreciated, numerous variations and modifications will becomeapparent to those skilled in the art. It is intended that the followingclaims be interpreted to embrace all such variations and modifications.

What is claimed is:
 1. A method of treating fibromyalgia, comprising: administering a therapeutically effective amount of a sensory stimulus to a person, wherein the sensory stimulus includes one or more visual stimuli and one or more auditory stimuli, wherein the sensory stimulus alternates between a first sensory stimuli including simultaneously providing a left visual stimuli pattern to a left eye of the person and a right auditory stimuli pattern to a right side of a head of the person, and a second sensory stimuli including simultaneously providing a right visual stimuli pattern to a right eye of the person and a left auditory stimuli pattern to a left side of the head of the person, wherein one or more of the left auditory stimuli patterns and the right auditory stimuli patterns comprises a sequence of stimuli patterns including a first stimuli pattern, and a second stimuli pattern, wherein the first stimuli pattern includes a first pulse frequency between 0.25 Hz and 0.75 Hz, 1.25 Hz and 1.75 Hz, 2 Hz and 4 Hz, 3.75 Hz and 4.25 Hz, 4.4 Hz and 6 Hz, or 6 Hz and 9 Hz, and wherein the second stimuli pattern includes a second pulse frequency between 4.4 Hz and 9 Hz.
 2. The method of claim 1, further comprising: treating one or more symptoms of fibromyalgia, wherein the one or more symptoms are selected from a group including anxiety, pain, depression, and one or more sleep disorders.
 3. The method of claim 1, wherein at least one of the one or more visual stimuli includes an amplitude modulated light source.
 4. The method of claim 1, wherein at least one of the one or more visual stimuli includes a sinusoidally varying light source.
 5. The method of claim 1, wherein at least one of the one or more auditory stimuli includes an amplitude modulated audio frequency.
 6. The method of claim 1, wherein the sequence of stimuli patterns further includes a third stimuli pattern, wherein the third stimuli pattern is different from the first stimuli pattern and the second stimuli pattern.
 7. The method of claim 6, wherein at least one of the first stimuli pattern, the second stimuli pattern, the third stimuli pattern, or repeatedly pulsing a light occurs for a predetermined time interval.
 8. The method of claim 7, wherein the predetermined time interval is between approximately 25 and 45 seconds.
 9. The method of claim 1, further comprising: periodically providing a sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the person, a right visual stimuli pattern to the right eye of the person, a left auditory stimuli pattern to the left side of the head, and a right auditory stimuli pattern to the right side of the head of the person.
 10. The method of claim 1, further comprising: alternating sensory stimuli between a third sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the person and a left auditory stimuli pattern to the left side of the head, and a fourth sensory stimuli including simultaneously providing a right visual stimuli pattern to the right eye of the person and a right auditory stimuli pattern to the right side of the head of the person.
 11. The method of claim 10, further comprising: alternating sensory stimuli between a fifth sensory stimuli including simultaneously providing a left auditory stimuli pattern to the left side of the head and a right auditory stimuli pattern to the right side of the head, and a sixth sensory stimuli including simultaneously providing a left visual stimuli pattern to the left eye of the person and a right visual stimuli pattern to the right eye of the person.
 12. The method of claim 1, further comprising: providing a headset to be worn on a head of the person; and wherein the left auditory stimuli pattern comprises generating the left auditory stimuli pattern with a left bone conduction transducer of the headset; and wherein the right auditory stimuli pattern comprises generating the right auditory stimuli pattern with a right bone conduction transducer of the headset.
 13. The method of claim 1, wherein the one or more of the left auditory stimuli patterns or the right auditory stimuli patterns includes an auditory frequency of approximately 240 Hz to 480 Hz.
 14. The method of claim 1, wherein one or more of the left visual stimuli pattern or right visual stimuli pattern comprises repeatedly pulsing a light at one or more of a first pulse frequency, a second pulse frequency less than the first pulse frequency, or a third pulse frequency less than the first pulse frequency and the second pulse frequency.
 15. The method of claim 1, wherein the sequence of stimuli patterns each include a pulse frequency including a pulse period, wherein a portion of the pulse period includes a stimulus of an auditory frequency of between approximately 240 Hz and 480 Hz.
 16. The method of claim 15, wherein the portion of the pulse period is one half of the pulse period.
 17. The method of claim 1, further comprising: obtaining a measurement of the person using a sensor; determining a state of the person from the obtained measurement; and modifying the sensory stimulus according to the state of the person.
 18. The method of claim 17, wherein the sensor comprises at least one of a heart rate sensor, a heart rate variability (HRV) sensor, a temperature sensor, a motion sensor, a galvanic skin response sensor, an accelerometer, an EEG, and an EMG.
 19. The method of claim 17, wherein the state of the person comprises a state of sleep or a level or a change in a level of relaxation or a level of arousal.
 20. A system for treating fibromyalgia, comprising: a headset configured to be worn on a head of a person; wherein the headset is configured to administer a therapeutically effective amount of a sensory stimulus to the person; and wherein the sensory stimulus includes one or more visual stimuli and one or more auditory stimuli, wherein the sensory stimulus alternates between a first sensory stimuli including simultaneously providing a left visual stimuli pattern to a left eye of the person and a right auditory stimuli pattern to a right side of a head of the person, and a second sensory stimuli including simultaneously providing a right visual stimuli pattern to a right eye of the person and a left auditory stimuli pattern to a left side of the head of the person, wherein one or more of the left auditory stimuli patterns and the right auditory stimuli patterns comprises a sequence of stimuli patterns including a first stimuli pattern, and a second stimuli pattern, wherein the first stimuli pattern includes a first pulse frequency between 0.25 Hz and 0.75 Hz, 1.25 Hz and 1.75 Hz, 2 Hz and 4 Hz, 3.75 Hz and 4.25 Hz, 4.4 Hz and 6 Hz, or 6 Hz and 9 Hz, and wherein the second stimuli pattern includes a second pulse frequency between 4.4 Hz and 9 Hz.
 21. The system of claim 20, wherein at least one of the one or more visual stimuli includes at least one of an amplitude modulated light source and a sinusoidally varying light source; and wherein at least one of the one or more auditory stimuli includes an amplitude modulated audio frequency. 